Critically Ill ICU Patients Under Casirivimab- and/or Tocilizumab Application

Completed

• Conditions: Interleukin 6; COVID-19; Outcome, Fatal; Tocilizumab; Critically Ill
• Interventions: Drug: treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T)

• Registration Number: NCT06233357
• Lead Sponsor: University of Ulm

Brief Summary

In a retrospective observational study, critically ill COVID-19 patients admitted to the ICU with the CoV-2 delta-variant between august 2021 and february 2022 were evaluated (ethics application nr. 129/22 of the ethics commssion of the university Ulm.

Detailed Description

According to the recommendations, IgG seronegative SARSCoV2-Spike antibody (\< 0,80 U/ml) COVID-19 patients were treated with 1 dose of subcutaneous casirivimab and imdevimab, 1200 mg (600 mg of each). Patients with CRP \> 75 mg/l or IL-6 \> 75 ng/l were treated with one dose of intravenous tocilizumab 8 mg/kg body weight. 28-day mortality and 30-day time course of leukocyte counts and serum concentrations of C-reactive protein (CRP), procalcitonin (PCT), interleukin 6 (IL-6) and ferritin in 4 patient groups, i. e., treated without (N) or with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T), were evaluated.

Study Timeline

• Study Start: 2021-08-01
• Primary Completion: 2022-04-28
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-31
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

• Clinical diagnosis of COVID-19
• CoV-2 delta-variant
• critically ill patients
• ICU

Exclusion Criteria

• tuberculosis
• active hepatitis
• HIV

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
C, treated with casirivimab / imdevimab	treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T)	Active comparator
C + T, treated with casirivimab / imdevimab and tocilizumab	treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T)	Active comparator
T, Treated with Tocilizumab	treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T)	Active comparator

Primary Outcome Measures

Name	Time	Method
Mortality rates in the 4 groups	28-day mortality	Number of survivors and nonsurvivors

Secondary Outcome Measures

Name	Time	Method
C-reactive protein in 4 groups	30-days	Routine blood analysis over time
Ferritin serum concentrations in 4 groups	30-days	Routine blood analysis over time
Leukocyte count in 4 groups	30-days	Routine blood analysis
Interleukin 6 serum concentrations in 4 groups	30-days	Routine blood analysis over time
Procalcitonin serum concentrations in 4 groups	30-days	Routine blood analysis over time

Trial Locations

Locations (1)

Clinic of Anesthesiology; 🇩🇪 Ulm, Germany